First treatment for late-stage dry AMD rejected by UK drug regulator

The first potential treatment for geographic atrophy (GA) or late stage dry age-related macular degeneration (AMD) has been rejected by the Medicines and Healthcare products Regulatory Agency (MHRA). 

The decision is a significant setback for those affected by GA, who have been waiting for progress in managing this challenging condition.

The drug manufacturer Apellis, has revealed that the MHRA has rejected Syfovre (pegcetacoplan) for use in the UK, as a treatment for GA.

GA causes gradual and irreversible damage to the retina, leading to severe sight loss.

While the MHRA did recognise the effect of Syfovre on slowing the rate of progression of GA, they were concerned about whether it meaningfully improved patients’ ability to see and manage daily tasks during the trial period. 

The Macular Society knows the decision not to approve this treatment is disappointing, but remains optimistic about ongoing research and the development of other potential treatments.

Commenting on the decision, director of research at the Macular Society Dr Peter Bloomfield, said: "This is undoubtedly disappointing news for people living with macular disease, many of whom have been hoping for a breakthrough. However, we want to reassure patients that this is not the end of the road. There are several promising treatments at different stages in development, and we remain committed to supporting research and advocating for better options for the future.

"For now, our priority is to continue providing support to those affected by macular disease and ensure they have access to the resources and information they need. The Macular Society will also keep funding research to drive progress in this area and support clinical trials to enable early access to new therapies."

The Macular Society is dedicated to improving the lives of those with macular disease through support, advocacy, and research. While this decision marks a setback, it highlights the need for continued collaboration among researchers, healthcare providers, and policymakers to address the urgent needs of patients.